The present invention relates to fluid delivery systems and methods and assemblies for making connections. More particularly, the invention relates to fluid delivery systems and methods and assemblies for making connections which maintain the sterility of a fluid, for example, a biological fluid, which passes through the connector assembly.
Connector assemblies have been developed to handle fluids, e.g., biological fluids, while preserving their condition. More particularly, connectors have been developed to preserve the condition of a fluid, or maintain a fluid free of contaminants. Freedom from contaminants refers to a relative amount of contaminants and is variously defined according to a specific industry, fluid and/or intended use. For example, a biological fluid which is substantially free of contaminants is considered free of viable micro-organisms, and is typically referred to as xe2x80x9csterilexe2x80x9d. Connector assemblies for use with biological fluids, for example, have been fashioned to preserve sterility of the fluid.
Attempts have been made to develop connector assemblies which isolate a fluid from the ambient environment of the connector, and from contaminants entrained in the ambient. Such connectors typically define a fluid conduit which is isolated from the ambient. Some conventional connector assemblies include mating male and female connectors having opposing, exposed surfaces. One surface may comprise the surface of a membrane, for example, while the other surface may comprise the surface of a rubber septum forming a blind end of an elastic, collapsible tube. These surfaces may be wiped with an antiseptic, then resiliently urged in contact when the connectors are coupled. Other conventional connector assemblies provide a removable protective cover on each opposing surface to be contacted. These covers must be removed prior to actually coupling the connectors.
Many problems are associated with these conventional connector assemblies. For example, wiping the surfaces with an antiseptic or removing the covers of these conventional connector assemblies may not sufficiently protect the fluid flowing through these assemblies. The surfaces are wiped and the covers are removed usually by hand. Although the attendant may use surgical gloves, a gloved finger may trail the antiseptic wipe along the protected surface, depositing on the surface contaminants that were on the glove. To unfasten and remove a cover, the gloved hand must manipulate the removable cover in intimate proximity to the protected surface under the cover, again risking incidental contact and the transmission of contaminants between the glove and the protected surface.
In addition, once the surfaces are wiped with an antiseptic or the protective covers are removed from the protected surfaces, the surfaces are exposed to the contaminant-laden ambient environment. For example, as the connectors are brought together, dust, micro-organisms, and other airborne contaminants may contact the protected surfaces, even if the connectors are quickly mated. Thus, while these conventional connector assemblies have been developed to form a sterile connection, none adequately protect the fluid flowing through the connector assembly.
In accordance with one aspect, the present invention is directed to a fluid delivery system comprising a connector assembly and a container for holding fluids. The connector assembly includes a first fitting defining a first aperture and a second fitting which is couplable to the first fitting and which defines a second aperture. The first fitting includes at least one removable contamination containment layer sealing the first aperture.
In addition, the first fitting includes a stem member having a head axially moveable from a first position wherein the head of the stem member is sealed within the first aperture of the second fitting. The container includes a wall, and the second fitting is directly associated with the wall of the container.
In accordance with another aspect, the present invention is directed to a fluid delivery system comprising a connector assembly and a container for holding fluids. The connector assembly includes a first fitting defining a first aperture and a second fitting which is couplable to the first fitting and which defines a second aperture. The first fitting includes at least one removable contamination containment layer sealing the first aperture. In addition, the first fitting includes a stem member having a head axially moveable from a first position wherein the head of the stem member is sealed within the first aperture of the second fitting. The second fitting comprises a flange having an aperture and tongues extending from the flange, wherein the tongues are adapted to couple the first and second fittings. The container includes a wall, and the second fitting is directly associated with the wall of the container.
The novel features and characteristics of this invention are set forth with particularity in the appended claims. However, the invention may best be understood with reference to the drawings, described below, and the accompanying detailed description of preferred embodiments.